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FDA 510(k)

BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter

K-Number: K231653 · 2023-07-03

ApplicantThrombolex, Inc.
Decision Date2023-07-03
Product CodeQEY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Thrombolex, Inc.. It received FDA 510(k) clearance on 2023-07-03 under 510(k) number K231653. The device is classified under product code QEY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter?

BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter is a medical device that received FDA 510(k) clearance on 2023-07-03. The listed applicant is Thrombolex, Inc.. The 510(k) number is K231653.

When did BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter receive FDA 510(k) clearance?

BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter received FDA 510(k) clearance on 2023-07-03, under 510(k) number K231653.

Who is the listed applicant for BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter?

The FDA 510(k) record lists Thrombolex, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter?

The FDA product code for BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter is QEY.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06433011The RAPID - PE Study: RESCUE Advanced Protocol for the Treatment of Pulmonary EmbolismRECRUITING

Other records listing Thrombolex, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K222095BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101K211061BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter (Ref. 7210), BASHIR Plus 20 Endovascular Catheter (Ref. 7220), BASHIR Plus 30 Endovascular Catheter (Ref. 7230), BASHIR Plus 40 Endovascular Catheter (Ref. 7240)K193071Bashir Plus Endovascular CatheterK192598Bashir S-B Endovascular Catheter, Ref. No. 7101K183290Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200

Related Devices (Code: QEY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260149Versus™ Catheter (VS110-9NB)Liquet Medical, Inc.K251318VariFuse Adjustable Infusion CatheterArgon Medical Devices, Inc.K241851Versus™ Catheter (VS110-8B)Liquet Medical, Inc.K222095BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101Thrombolex, Inc.K220866EKOS+ Endovascular DeviceBoston ScientificK213422EkoSonic Endovascular Device, EKOS+ Endovascular DeviceBoston Scientific Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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